Risk-Based Monitoring in Clinical Trial: A Cross-Functional Approach

Risk-based monitoring (RBM) extends beyond the idea of simply reducing onsite monitoring by performing less than 100% source document verification. Rather, a comprehensive implementation of RBM can provide an adaptable, integrated approach to monitoring that focuses on identifying and addressing risks to patient safety and data quality.

In this process, a risk assessment discussion takes place at the planning stage and options for tailoring monitoring methods and resources to address those risks.  During our initial stage, we share insights from NAMSA’s client-centered approach to RBM highlighting how cross-functional collaboration, supported by core processes and tools, provides an implementation of RBM that is customized to a study’s risk profile. 

It is also demonstrated how ongoing risk evaluation may be informed by both objective study data and subjective scoring of site performance. The spectrum of choices available for shifting monitoring resources in response to changing risk metrics is also discussed. Particular attention may be given to the need for metrics to account for potentially abrupt shifts in site practices which could occur due to changing personnel or effective corrective and preventive actions. 

The emphasis of the critical role that training plays in effectively shifting from traditional monitoring to risk-based monitoring is also part of the discussion. As well as key elements of monitor and site training for successful implementation of RBM.

In this webinar you will learn:

• What are the benefits of Risk-Based Monitoring
• What are the keys to effective Risk-Based Monitoring
• How NAMSA uses Risk-Based Monitoring

The speakers for this webinar are Sharon Herbert,PhD, Senior Medical Research Manager and Tyson Rogers, Senior Principal Medical Research Biostatistician.

SPEAKER BIOS

Sharon Herbert, PhD

Senior Medical Research Manager

Sharon Herbert received her B.S degree in Biochemistry and Physiology from the University of the Western Cape in Cape Town, South Africa, and a PhD in Molecular Genetics from Imperial College School of Science, Technology and Medicine in London, England. Sharon also holds a Masters in Business Administration from the University of Cape Town’s Graduate School of Business. Sharon’s extensive experience in medical research includes both pre-clinical and clinical research. Her pre-clinical research experience includes conducting post-doctoral research in the area of Genetics and Immunology at the University of Cape Town, and evaluating the commercialization potential of basic medical research outputs as a Technology Transfer manager at the South African Medical Research Council. Sharon has international experience managing multi-center pharmaceutical, medical device, and IVD clinical studies, in a wide range of therapeutic areas. Sharon’s clinical study implementation expertise includes protocol, consent, and case report form development, site feasibility, identification and start-up, site training and management, monitor oversight, safety event review, clinical report writing, and regulatory submissions.

Tyson Rogers

Senior Principal Medical Research Biostatistician

Tyson Rogers is a Senior Principal Biostatistician with NAMSA. He received his Masters in biostatistics from UCLA and has been working on clinical trials for the past 12 years helping companies both large and small develop and execute on their evidence plans. His statistical interests focus on trial design, including strategy for interim analyses and adaptive sample size re-estimation.